Scientific Opinion on the safety and efficacy of Ronozyme® P (6-phytase) as a feed additive for salmonids
Question number: EFSA-Q-2009-00535
Adopted: 10 November 2010

Summary
Following a request from European Commission, the Panel on Additives and products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Ronozyme® P (6-phytase) as a feed additive for salmonids.

Ronozyme® P is a liquid preparation of 6-phytase produced by a genetically modified strain of Aspergillus oryzae. The safety of the genetic modification of the current production strain has been previously established by EFSA in 2004. The product has been fully described in previous opinions and the safety of the product for the consumers, users and the environment has been assessed. In the view of the FEEDAP Panel, the use of the product in salmonids would not affect the conclusions reached in previous opinions.

A tolerance trial with rainbow trout (Oncorhynchus mykiss) and five short-term efficacy studies (four with rainbow trout and one with Atlantic salmon (Salmo salar)) were performed with Ronozyme® P 20000 (L).

The results from the tolerance trial in which fish were fed 100-fold the maximum recommended dose showed that Ronozyme® P is safe for salmonids at the maximum dose of 2000 FYT/kg.

Phosphorus utilization was improved in two trials performed in rainbow trout at a dose level of 500 FYT/kg and above, and in one trial performed in Atlantic salmon at a dose of 750 FYT/kg and above. Therefore, the FEEDAP Panel concludes that Ronozyme® P is efficacious in salmonids at the minimum recommended dose of 750 FYT/kg.

The use of the additive allows the use of diets with a lower level of inorganic P, which may in turn reduce the excretion of P.

Opinion (PDF)